AB0938 SAFETY PROFILE OF BIMEKIZUMAB AT WEEK 16 IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS AND PSORIATIC ARTHRITIS: RESULTS FROM FOUR PLACEBO-CONTROLLED PHASE 3 STUDIES
Authors: D. Poddubnyy, L. S. Gensler, P. J. Mease, A. M. Orbai, R. B. Warren, B. Ink, U. Massow, D. Assudani, C. Fleurinck, V. Shende, J. Smith, L. Peterson, K. White, R. B. M. Landewé
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. <h3>Objectives</h3> To report Week (Wk) 0–16 safety of BKZ and placebo (PBO) in 2 axial spondyloarthritis (axSpA) and 2 psoriatic arthritis (PsA) phase 3 studies. <h3>Methods</h3> Patients (pts) in 2 safety pools received ≥1 dose of subcutaneous BKZ 160 mg or PBO every 4 wks during Wks 0–16 (double-blind phase) of BE MOBILE 1 + BE MOBILE 2 in axSpA (NCT03928704; 03928743); BE OPTIMAL + BE COMPLETE in PsA (NCT03895203; 03896581) (<b>Figure 1</b>) <sup>[1-4]</sup>. <h3>Results</h3> Wk 16 completion rates: 95.8% (PBO), 97.1% (BKZ) in axSpA; 95.9% (PBO), 97.1% (BKZ) in PsA. Most frequently reported treatment-emergent adverse events in ≥3% pts on BKZ were nasopharyngitis, upper respiratory tract infection, oral candidiasis and headache (<b>Table 1</b>). See <b>Table</b> for adverse events of special interest. Serious infections occurred in 5 pts (axSpA: 1 [0.4%] PBO, 1 [0.3%] BKZ; PsA: 0 PBO, 3 [0.4%] BKZ). Fungal infections were all local and reported as mild/moderate by investigators; more <i>Candida</i> infections were seen on BKZ (axSpA: 15 pts [4.3%]; PsA: 18 [2.6%]) than PBO (axSpA: 0; PsA: 2 [0.5%]) and led to discontinuation by 3 pts on BKZ (1 axSpA, 2 PsA). In axSpA pts, uveitis occurred in 11 (4.6%) on PBO and 2 (0.6%) on BKZ; inflammatory bowel disease occurred in 1 (0.4%) pt on PBO, 2 (0.6%) on BKZ. No uveitis/IBD cases in PsA by Wk 16 (PBO or BKZ). No deaths, active tuberculosis, suicidal ideation/behaviour, or major adverse cardiac events were reported in any study to Wk 16. <h3>Conclusion</h3> The overall safety profile of BKZ was in line with previous phase 2 trials in axSpA and PsA, with a low rate of discontinuation. As expected, due to inhibition of IL-17, there was a higher rate of oral candidiasis compared to PBO. <h3>References</h3> [1]Deodhar A. Ann Rheum Dis. 2022;81:772–3; [2]Van der Heijde D. Ann Rheum Dis. 2022;81:12–3; [3]McInnes I. Ann Rheum Dis. 2022;81:206–7; [4]Merola J. Ann Rheum Dis. 2022;81:167–9; [5]Boel A. Ann Rheum Dis. 2019;78:1545–9. <h3>Acknowledgements</h3> This study was funded by UCB Pharma. Medical writing support was provided by Costello Medical, funded by UCB Pharma. <h3>Disclosure of Interests</h3> Denis Poddubnyy Speakers bureau: AbbVie, BMS, Eli Lilly, MSD, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Biocad, Eli Lilly, Gilead, GSK, MSD, MoonLake, Novartis, Pfizer, Samsung Bioepis and UCB Pharma, Grant/research support from: AbbVie, Lilly, MSD, Novartis and Pfizer, Lianne S. Gensler Consultant of: AbbVie, Acelyrin, Eli Lilly, Fresenius Kabi, Janssen, Novartis, Pfizer and UCB Pharma, Grant/research support from: Novartis and UCB Pharma paid to institution, Philip J Mease Speakers bureau: AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Acelyrin, Aclaris, Amgen, BMS, Boehringer Ingelheim, Eli Lilly, Galapagos, Gilead, GSK, Janssen, MoonLake, Novartis, Pfizer, Sun Pharma and UCB Pharma, Grant/research support from: AbbVie, Amgen, BMS, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Sun Pharma and UCB Pharma, Ana-Maria Orbai Consultant of: BMS, Janssen, Sanofi and UCB Pharma, Grant/research support from: AbbVie, Amgen and Janssen paid to institution, Richard B. Warren Speakers bureau: Astellas, DiCE, GSK and Union, Consultant of: AbbVie, Almirall, Amgen, Arena, Astellas, Avillion, Biogen, Boehringer Ingelheim, BMS, Celgene, Eli Lilly, GSK, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi and UCB Pharma, Grant/research support from: AbbVie, Almirall, Janssen, LEO Pharma, Novartis and UCB Pharma paid to institution, Barbara Ink Shareholder of: AbbVie, GSK and UCB Pharma, Employee of: UCB Pharma, Ute Massow Employee of: UCB Pharma, Deepak Assudani Shareholder of: UCB Pharma (at time of study), Employee of: UCB Pharma (at time of study), GSK, Carmen Fleurinck Employee of: UCB Pharma, Vish Shende Employee of: UCB Pharma, julie smith Employee of: UCB Pharma, Luke Peterson Shareholder of: UCB Pharma, Employee of: UCB Pharma, Katy White Shareholder of: UCB Pharma, Employee of: UCB Pharma, Robert B.M. Landewé Consultant of: AbbVie, AstraZeneca, BMS, Novartis, Pfizer, Eli Lilly and UCB Pharma, Grant/research support from: AbbVie, Pfizer, Novartis and UCB Pharma, Employee of: Owner of Rheumatology Consultancy BV, an AMS company under Dutch law.